FDA.reportPublic FDA data

SMITH & NEPHEW ORTHOPAEDICS AG

Matched from indexed company URL: Smith & Nephew Orthopaedics AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96133693002807893SMITH & NEPHEW ORTHOPAEDICS AG1N2026-01-01SCHACHENALLEE 29 DAMMWEG 39 AARAU Aargau CH CH-5001
30068533193006853319Smith & Nephew Orthopaedics AG1N2020-04-25Oberneuhofstrasse 10a/10d Baar Zug CH 6340

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1482251041139062K994126MODULAR-PLUS REVISION STEMLWJ2000-05-04
1481561041139062K994126MODULAR-PLUS REVISION STEMLWJ2000-05-04
1481561276675979K962137GENESIS II CONSTRAINED SYSTEMJWH1996-08-02
1482251276675979K962137GENESIS II CONSTRAINED SYSTEMJWH1996-08-02
1482251837728357K960094REFLECTION DUAL DIMENSION SHELLMBL1996-03-27
1481561837728357K960094REFLECTION DUAL DIMENSION SHELLMBL1996-03-27
1482251049157024K951987GENESIS II TOTAL KNEE SYSTEMJWH1995-08-22
1481561049157024K951987GENESIS II TOTAL KNEE SYSTEMJWH1995-08-22
1481561764871215K946236PROFIX CONFORMING PLUS TIBIAL INSERTKWH1995-07-06
1482251764871215K946236PROFIX CONFORMING PLUS TIBIAL INSERTKWH1995-07-06
1481561356488978K933958RICHARDS TOTAL KNEE SYSTEMJWH1995-01-09
1482251356488978K933958RICHARDS TOTAL KNEE SYSTEMJWH1995-01-09
1482251205061522K932755REFLECTION ACETABULAR COMPONENTLPH1994-05-06
1481561205061522K932755REFLECTION ACETABULAR COMPONENTLPH1994-05-06
1482251696261131K250571CATALYSTEM Femoral StemsLZO2025-03-28
1482251574932415K242375OR3O Dual Mobility SystemLPH2024-10-07
1482251461408438K240381CATALYSTEM Femoral StemsLZO2024-06-27
1482251793688193K231448TANDEM Hip SystemLZY2023-07-19
1482251105321410K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial BaseplatesJWH2023-05-04
1482251394016542K211548POLARSTEM Calcar Reamer GuideLZO2021-07-19
1482251565111099K211176Smith & Nephew Hip SystemsLPH2022-07-01
1482251410259185K210837Smith & Nephew Plates and ScrewsHRS2021-06-29
1482251205362941K203175POLARSTEM Cemented Femoral StemLZO2021-07-22
1482251615087830K191002OR3O Dual Mobility SystemLPH2019-10-31
1482251451802389K181533EVOS Wrist Fracture Plating SystemHRS2018-08-09
1481561636636564K181366REDAPT Porous Acetabular ShellLPH2018-09-24
1482251636636564K181366REDAPT Porous Acetabular ShellLPH2018-09-24
1482251076186527K171934Birmingham Hip (BH) Dual Mobility InsertLPH2017-11-30
1481561076186527K171934Birmingham Hip (BH) Dual Mobility InsertLPH2017-11-30
1482251018470269K162078EVOS Small Fragment Plating SystemHRS2016-11-18
1481561771638920K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HALZO2015-04-20
1482251771638920K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HALZO2015-04-20
1481561931092842K143096SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HALZO2015-03-24
1482251931092842K143096SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HALZO2015-03-24
1482251062996275K132435SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALSLZO2013-10-22
1481561062996275K132435SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALSLZO2013-10-22
1482251912067678K132296D-RAD SMART PACKHRS2014-01-07
1482251956699742K130728POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HALZO2013-10-10
1481561956699742K130728POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HALZO2013-10-10
1482252011430938K123598SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONJDI2013-06-28
1481562011430938K123598SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONJDI2013-06-28
1481561336710839K122296SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATINGLZO2012-08-28
1482251336710839K122296SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATINGLZO2012-08-28
1482251281562659K122244POLARCUP DUAL MOBILITY SYSTEMLPH2012-08-23
1481561281562659K122244POLARCUP DUAL MOBILITY SYSTEMLPH2012-08-23
1481561441454906K121714SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTSHSD2012-09-07
1482251441454906K121714SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTSHSD2012-09-07
1481561879465352K121443JOURNEY II CR KNEE SYSTEMJWH2012-08-13
1482251879465352K121443JOURNEY II CR KNEE SYSTEMJWH2012-08-13
1482251719921140K120211SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATINGLZO2012-07-19
1481561719921140K120211SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATINGLZO2012-07-19
1482251925812843K113038SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTSHSX2012-01-05
1481561925812843K113038SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTSHSX2012-01-05
1482251037784343K113012PROMOS MODULAR SHOULDER SYSTEMKWS2012-01-05
1481561037784343K113012PROMOS MODULAR SHOULDER SYSTEMKWS2012-01-05
1481561810278205K111711JOURNEY II BCS KNEE SYSTEMJWH2011-09-16
1482251810278205K111711JOURNEY II BCS KNEE SYSTEMJWH2011-09-16
1482251734770834K110135POLARCUP DUAL MOBILITY SYSTEMLPH2011-10-14
1481561734770834K110135POLARCUP DUAL MOBILITY SYSTEMLPH2011-10-14
1482251418406937K100412BIOLOX DELTA CERAMIC FEMORAL HEADSLZO2010-05-05
1482251987152292K093991SLR-PLUS STANDARD AND LATERAL FEMORAL STEMSLZO2010-04-15
1481561987152292K093991SLR-PLUS STANDARD AND LATERAL FEMORAL STEMSLZO2010-04-15
1482251943884768K083762BIOLOX DELTA CERAMIC FEMORAL HEADSLZO2009-03-11
1482251965673194K082371SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEMLZO2009-02-09
1481561965673194K082371SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEMLZO2009-02-09
1482251479441759K081111LEGION HINGE KNEE SYSTEMKRO2008-07-23
1481561479441759K081111LEGION HINGE KNEE SYSTEMKRO2008-07-23
1482251419659272K081016SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEMPHX2008-09-05
1481561419659272K081016SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEMPHX2008-09-05
1481561598658412K080875PIGALILEO 4TH GENERATION SYSTEMHAW2008-07-18
1482251598658412K080875PIGALILEO 4TH GENERATION SYSTEMHAW2008-07-18
1481561330125839K072858TC-PLUS PRIMARY KNEE SYSTEMJWH2007-11-20
1482251330125839K072858TC-PLUS PRIMARY KNEE SYSTEMJWH2007-11-20
1482252013772182K072852SL-PLUS STANDARD AND LATERAL HIP STEMSLZO2008-06-09
1481562013772182K072852SL-PLUS STANDARD AND LATERAL HIP STEMSLZO2008-06-09
1482251532217532K070278POLARCUP DUAL MOBILITY SYSTEMLPH2007-04-16
1481561532217532K070278POLARCUP DUAL MOBILITY SYSTEMLPH2007-04-16
1482251221988732K063578PROMOS MODULAR SHOULDER SYSTEMHSD2007-03-02
1481561221988732K063578PROMOS MODULAR SHOULDER SYSTEMHSD2007-03-02
1482251867576211K061362PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEMHAW2006-10-06
1481561867576211K061362PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEMHAW2006-10-06
1482251220765291K060742LEGION COBALT CHROME REVISION KNEE SYSTEMJWH2006-05-03
1482251656548265K032709MODULAR PLUS HIP STEMLWJ2003-09-23
1481561656548265K032709MODULAR PLUS HIP STEMLWJ2003-09-23
1482251869166274K032126PROMOS SHOULDERHSD2004-01-08
1481561869166274K032126PROMOS SHOULDERHSD2004-01-08
1482251797553406K030971MODIFICATION TO MODULAR PLUS REVISION STEMLWJ2003-04-24
1481561797553406K030971MODIFICATION TO MODULAR PLUS REVISION STEMLWJ2003-04-24
1481561874294161K023743SMITH & NEPHEW GLOBAL BIPOLAR SYSTEMKWY2003-01-23
1482251874294161K023743SMITH & NEPHEW GLOBAL BIPOLAR SYSTEMKWY2003-01-23
1482251825447328K022120MPF ACETABULAR CUP GENERATION 2LZO2002-07-24
1481561825447328K022120MPF ACETABULAR CUP GENERATION 2LZO2002-07-24
1482251576237599K011719PLUS CANCELLOUS BONE SCREWSHWC2001-07-02
1481561576237599K011719PLUS CANCELLOUS BONE SCREWSHWC2001-07-02
1482251905173123K002747REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTSLPH2000-12-15
1482251177484309K000666TC-PLUS SOLUTION KNEEJWH2000-10-13
1481561177484309K000666TC-PLUS SOLUTION KNEEJWH2000-10-13
1481561014651288
1482251014651288
1482251020689723
1481561020689723
1481561038729722
1482251105855889
1481561105855889
1481561170944603
1482251170944603
1481561171552177
1482251171552177
1481561198436024
1482251209041312
1481561209041312
1481561277573308
1481561312654591
1482251354195872
1481561354195872
1481561376303751
1482251500173126
1481561500173126
1482251538691506
1481561538691506

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZO262025-03-28
LPH162024-10-07
JWH162023-05-04
HSD62012-09-07
LWJ62003-09-23
HRS42021-06-29
HAW42008-07-18
JDI22013-06-28
HSX22012-01-05
KWS22012-01-05
PHX22008-09-05
KRO22008-07-23
KWY22003-01-23
HWC22001-07-02
MBL21996-03-27
KWH21995-07-06
LZY12023-07-19